Effect of Methylphenidate on Cancer-related Fatigue in Patients Treated for a Brain Tumor During Childhood or Adolescence: Protocol for a Randomized, Double-blind, Placebo-controlled Crossover Trial - the EMBRAIN Trial

NCT06905587 Phase 3 RECRUITING

Cancer-related fatigue is a common and debilitating late effect in pediatric brain tumor survivors. Currently, evidence-based recommendations to ameliorate this condition are lacking. The researchers will investigate the ability of methylphenidate to improve fatigue and cognition in pediatric brain tumor survivors suffering from cancer-related fatigue. Methylphenidate is a drug (central nervous stimulant) most commonly used in the treatment of hyperkinetic disorders such as attention-deficit/hyperactivity disorder (ADHD). If methylphenidate shows an effect, the prospects are important for this patient group, since methylphenidate may then be included as part of the treatment of brain tumor-related fatigue.

Details

Lead sponsor	Odense University Hospital
Phase	Phase 3
Status	RECRUITING
Enrolment	50
Start date	2025-09-02
Completion	2029-12

Conditions

• Brain Tumor, Pediatric
• Cancer-related Fatigue
• Methylphenidate

Interventions

• Methylphenidate (MPH)
• Placebo

Primary outcomes

• PedsQL Multidimensional Fatigue Scale (MFS) — At baseline, at Week 6, Week 16, and Week 20 (follow-up).
  Changes in patient self-reported fatigue (participants above 18 years of age) or parent proxy-reported fatigue (participants between 6-17 years of age) from baseline to week 6 of MPH or placebo treatment as measured by the PedsQL Multidimensional Fatigue Scale (MFS).

Countries

Denmark